CN102727943A - Biodegradable polymer braided stone-dissolving bile duct stent and preparation method thereof - Google Patents
Biodegradable polymer braided stone-dissolving bile duct stent and preparation method thereof Download PDFInfo
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- CN102727943A CN102727943A CN2012100289046A CN201210028904A CN102727943A CN 102727943 A CN102727943 A CN 102727943A CN 2012100289046 A CN2012100289046 A CN 2012100289046A CN 201210028904 A CN201210028904 A CN 201210028904A CN 102727943 A CN102727943 A CN 102727943A
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- lithodialysis
- biliary tract
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- biodegradable
- tract prosthesis
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Abstract
The invention, belonging to the field of biomedicine and bio-polymer material, particularly relates to a biodegradable polymer braided stone-dissolving bile duct stent and a preparation method thereof. The stent is prepared by braiding biodegradable polymers to obtain a porous reticulated or spiral tubular braided stent, and then coating a biodegradable drug loaded substance layer containing sodium cholate or/and edetate disodium on the inner surface and outer surface of the braided stent. Clinical outcomes show that the stone-dissolving bile duct stent of the invention has good radial supporting performance, can keep the bile duct open, can be degraded away in a certain time, has good biocompatibility, and lets almost no internal inflammation generate. Simultaneously, sodium cholate or/and edetate disodium slowly released by the polymer layer containing drugs can dissolve the formed stones and can prevent the re-formation of stones.
Description
Technical field
The invention belongs to biomedical sector and bioabsorbable polymer material field, be specifically related to a kind of lithodialysis biliary tract prosthesis and method for preparing of biodegradable polymer braiding.
Background technology
According to the clinical treatment statistics, calculus of bile duct has very high sickness rate, and traditional treatment mainly adopts surgical operation therapy, but wound is big, complication many and relapse rate is high; In addition, still have many patients weak with age or occur together other diseases and can not tolerate surgery treatment.Along with the development of endoscopic technic, pancreatic duct is got involved the technology (ERCP technology) of getting stone under the scope becomes the main treatment means of calculus of bile duct gradually, and has obtained excellent curative in recent years.But; Take out the calculus of bile duct (like calculus of bile duct multiple, huge, hard or that the position is special) of difficulty for some; Or be difficult to tolerate the patient of long-time endoscopic technic; Can only take directly to insert the bile duct plastic stent to guarantee that bile duct is unobstructed, described bile duct plastic stent does not have therapeutical effect to calculus itself.
Prior art discloses Biodegradable high-molecular polymer such as polycaprolactone, polylactic acid, has gathered hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane etc.; Has the good tissue compatibility; In the environment of body fluid, degrade through ester linkage hydrolyzing; Intermediate product lactic acid is normal glycometabolic product in the body, and final metabolite is CO
2And H
2O discharges in the Yi Congti and can not assemble at vitals, therefore has excellent biodegradable absorbability.Above-mentioned material is nontoxic, nonirritant, non-immunogenicity and biocompatibility are good, can be used safely in the body, simultaneously, is woven into biliary tract prosthesis and also need not takes out.
In addition; Materials such as collagen protein, phosphocholine, gelatin or chitosan and derivant thereof; Nontoxic, nonirritant, non-immunogenicity and biocompatibility are good, can be used safely in the body, and good adherent property is arranged; Can open with support and do not cause and come off, be the ideal material as medicament slow release/controlled release.
At present, discover that at China's common bile duct or mostly calculus of intrahepatic duct is bilirubin calculus or be main mixed type calculus with the bilirubin, therefore selecting dissolved stone medicine should be main with the dissolving bilirubin.Having research to show, is that the compound recipe Fructus Citri tangerinae oil sodium cholate Emulsion of main component can significantly be strengthened the solvability to bile pigment calculus with bile acid sodium, has become first cholelithiasis perfusion lithodialysis agent of examining through country of China.Also have research to show that edetate sodium has obvious effects to the dissolution of bile pigment calculus, does not find hepatic and renal function injure as yet in addition.But at present said medicine can only be through the method administration of regional perfusion, can only the orthopaedic surgical operations operation in or postoperative drainage pipe approach use, can't carry out the treatment that continues for a long time.
Therefore, clinical practice presses for the lithodialysis biliary tract prosthesis of relevant biodegradable polymer braiding, and this support is written into dissolved stone medicine in the biliary tract prosthesis of biodegradable polymer braiding, discharges in local slow after inserting bile duct, forms persistent litholytic effect.
Summary of the invention
The objective of the invention is to overcome defective of the prior art and deficiency, a kind of lithodialysis biliary tract prosthesis of biodegradable polymer braiding is provided; This support can keep under the unobstructed situation of biliary tract, the calculus that the dissolved stone medicine dissolving has formed with prevent that calculus from forming once more, and this support disappearances of degrading within a certain period of time do not need taking-up.
Particularly; The lithodialysis biliary tract prosthesis of biodegradable polymer braiding of the present invention; It is characterized in that; Adopt the Biodegradable high-molecular polymer to be woven into the piped braided support of porous network structure or helix structure, scribble the biodegradable medicine carrying material layer that contains dissolved stone medicine, process the lithodialysis biliary tract prosthesis that biodegradable polymer weaves at inner surface and the outer surface of said braided support;
The diameter of described braided support is 6-10mm, and length is 60-120mm; Wherein, the diameter of monofilament is 0.1-2.0mm;
Described dissolved stone medicine is selected from sodium cholate or/and disodium edetate;
The mass ratio of described sodium cholate and disodium edetate is 0-10mol: 0-10mol.
Among the present invention, described Biodegradable high-molecular polymer is selected from polycaprolactone, polylactic acid, gathers hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, to gather dioxane at least a;
Described biodegradable medicine carrying thing be selected from collagen protein, phosphocholine, gelatin or chitosan and derivant at least a.
Another object of the present invention provides the method for preparing of the lithodialysis biliary tract prosthesis of biodegradable polymer braiding, it is characterized in that it comprises step:
(1) adopting the Biodegradable high-molecular polymer is raw material, processes the monofilament that diameter is 0.1-2.0mm, and it is 6-10mm that monofilament is woven into diameter, and length is the braided support of 6-12cm;
(2) in 0-300mg: the ratio of 1ml; With biodegradable medicine carrying substance dissolves in acetic acid or glycerol; Processing solution, is that sodium cholate and the disodium edetate of 0-10mol: 0-10mol is dispersed in the said biodegradable medicine carrying substance solution with mass ratio, through soaking or spray treatment; Place the rack surface of above-mentioned steps (1) preparation, process the lithodialysis biliary tract prosthesis of biodegradable polymer braiding.
In the method for preparing according to the invention, the Biodegradable high-molecular polymer is selected from polycaprolactone, polylactic acid, gathers hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, to gather dioxane at least a.
In the method for preparing according to the invention, biodegradable medicine carrying material is that collagen protein, phosphocholine, gelatin or chitosan and derivant thereof are at least a.
In the method for preparing according to the invention, dissolved stone medicine is that sodium cholate and disodium edetate are at least a.
The lithodialysis biliary tract prosthesis of biodegradable polymer braiding of the present invention compared with prior art has the following advantages:
(1) the lithodialysis biliary tract prosthesis of this biodegradable polymer braiding is a raw material owing to select the Biodegradable high-molecular polymer for use, and the radial support better performances can prevent the narrow closure of bile duct proliferation, keeps biliary tract unobstructed;
(2) this support biocompatibility is better, and effect does not almost have inflammation in the body;
(3) contain calculus that sodium cholate that the polymer coating of medicine slowly discharges and/or disodium edetate solubilized formed and prevent that calculus from forming once more;
(4) the outer drug-loaded layer of Biodegradable high-molecular polymer can delay the degradation time of biodegradable polymer support; Reach the progressively purpose of degraded; The polymer coating post polymerization thing braided support of degrading fully can continue to support over a period to come; After the biodegradable polymer braided support is degraded fully, excrete, avoid being detained for a long time deleterious impact in the body.
The specific embodiment
The present invention is further described actual more than the following example below in conjunction with some specific embodiments.
Embodiment 1
The lithodialysis biliary tract prosthesis of preparation biodegradable polymer braiding:
(1) be raw material with the polycaprolactone, be processed into the monofilament that diameter is 0.2mm, it is that 8mm, length are the braided support of 80mm that monofilament is woven into diameter;
(2) in 20mg: the ratio of 1ml; Gelatin is dissolved in the acetic acid; Processing solution, is that sodium cholate and the disodium edetate of 1mol: 1mol is dispersed in the collagen solution with mass ratio, through immersion treatment; Place the braided support surface of above-mentioned steps (1) preparation, process the lithodialysis biliary tract prosthesis of biodegradable polymer braiding.
Embodiment 2
The lithodialysis biliary tract prosthesis for preparing the biodegradable polymer braiding through following steps:
(1) with polylactic acid: polyurethane is that 3: 5 ratios are raw material, is processed into the monofilament that diameter is 0.25mm, and it is that 10mm, length are the braided support of 120mm that monofilament is woven into diameter;
(2) in 30mg: the ratio of 1ml; Collagen protein is dissolved in the glycerol; Processing solution, is that sodium cholate and the disodium edetate of 1mol: 2mol is dispersed in the collagen solution with mass ratio, through spray treatment; Place the braided support surface of above-mentioned steps (1) preparation, process the lithodialysis biliary tract prosthesis of biodegradable polymer braiding.
Embodiment 3
The lithodialysis biliary tract prosthesis of preparation biodegradable polymer braiding:
With polylactic acid: the polyglycolic acid ratio is that 3: 4 copolymers are raw material, is processed into the monofilament that diameter is 0.21mm, and it is that 10mm, length are the braided support of 80mm that monofilament is woven into diameter; Ratio in 40mg: 1ml; Phosphocholine is dissolved in the glycerol; Processing solution, is that sodium cholate and the disodium edetate of 2mol: 1mol is dispersed in the phosphocholine solution, through immersion treatment with mass ratio; Place above-mentioned braided support surface, process the lithodialysis biliary tract prosthesis of biodegradable polymer braiding.
Embodiment 4
At first, with polycaprolactone: the polylactic acid ratio is that 2: 1 copolymers are raw material, is processed into the monofilament that diameter is 0.3mm, and again monofilament being woven into diameter is that 10mm, length are the braided support of 60mm; Then; In the ratio of 50mg: 1ml, chitosan is dissolved in the acetic acid, process solution; With mass ratio is that sodium cholate and the disodium edetate of 2mol: 3mol is dispersed in the chitosan solution; Through spray treatment, place described braided support surface, make the lithodialysis biliary tract prosthesis of biodegradable polymer braiding.
Embodiment 5
With polylactic acid: the polyglycolic acid ratio is that 3: 4 copolymers are raw material, is processed into the monofilament that diameter is 0.21mm, and it is that 10mm, length are the braided support of 80mm that monofilament is woven into diameter; In the ratio of 40mg: 1ml, phosphocholine is dissolved in the glycerol, process solution; With quality is that the sodium cholate of 10mol is dispersed in the phosphocholine solution; Through immersion treatment, place above-mentioned braided support surface, process the lithodialysis biliary tract prosthesis of biodegradable polymer braiding.
Embodiment 6
At first, with polycaprolactone: the polylactic acid ratio is that 2: 1 copolymers are raw material, is processed into the monofilament that diameter is 0.3mm, and again monofilament being woven into diameter is that 10mm, length are the braided support of 60mm; Then, in the ratio of 50mg: 1ml, chitosan is dissolved in the acetic acid; Processing solution, is that the disodium edetate of 10mol is dispersed in the chitosan solution with quality, through spray treatment; Place described braided support surface, make the lithodialysis biliary tract prosthesis of biodegradable polymer braiding.
The medication coat lithodialysis biliary tract prosthesis that the foregoing description makes is tried out, and the result shows, the lithodialysis biliary tract prosthesis of biodegradable polymer braiding of the present invention, and the radial support performance is good, can keep biliary tract unobstructed, the disappearance of can degrading within a certain period of time; And its biocompatibility is better, and effect seldom has inflammation in the body; Simultaneously, contain the slow sodium cholate that discharges of polymer coating of medicine and/or the calculus that the disodium edetate solubilized has formed, and can prevent that calculus from forming once more.
Claims (12)
1. the lithodialysis biliary tract prosthesis of biodegradable polymer braiding is characterized in that, scribbles the biodegradable medicine carrying material layer that contains dissolved stone medicine at inner surface and the outer surface of braided support, processes the lithodialysis biliary tract prosthesis that biodegradable polymer weaves;
The lithodialysis biliary tract prosthesis of described braiding adopts the Biodegradable high-molecular polymer to be woven into the piped braided support of porous network structure or helix structure, and diameter is 6-10mm, and length is 60-120mm; Wherein, the diameter of monofilament is 0.1-2.0mm;
Described dissolved stone medicine is selected from sodium cholate or/and disodium edetate, and its mass ratio is 0-10mol: 0-10mol.
2. by the described lithodialysis biliary tract prosthesis of claim 1, it is characterized in that the diameter of described braided support is that 8mm, length are 80mm, wherein, the diameter of monofilament is 0.2mm; Described sodium cholate and disodium edetate mass ratio are 1mol: 1mol.
3. by the described lithodialysis biliary tract prosthesis of claim 1, it is characterized in that the diameter of described braided support is that 10mm, length are 120mm, wherein, the diameter of monofilament is 0.25mm; Described sodium cholate and disodium edetate mass ratio are 1mol: 2mol.
4. by the described lithodialysis biliary tract prosthesis of claim 1, it is characterized in that the diameter of described braided support is that 10mm, length are 80mm, wherein, the diameter of monofilament is 0.21mm; Described sodium cholate and disodium edetate mass ratio are 2mol: 1mol.
5. by the described lithodialysis biliary tract prosthesis of claim 1, it is characterized in that the diameter of described braided support is that 10mm, length are 60mm, wherein, the diameter of monofilament is 0.3mm; Described sodium cholate and disodium edetate mass ratio 2mol: 3mol.
6. by the described lithodialysis biliary tract prosthesis of claim 1, it is characterized in that described dissolved stone medicine is the sodium cholate of 10mol.
7. by the described lithodialysis biliary tract prosthesis of claim 1, it is characterized in that described dissolved stone medicine is the disodium edetate of 10mol.
8. by the described lithodialysis biliary tract prosthesis of claim 1; It is characterized in that described Biodegradable high-molecular polymer is selected from polycaprolactone, polylactic acid, gathers hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid or gather dioxane.
9. by the described lithodialysis biliary tract prosthesis of claim 1, it is characterized in that described biodegradable medicine carrying material is selected from collagen protein, phosphocholine, gelatin or chitosan and derivant thereof.
10. the method for preparing of the described lithodialysis biliary tract prosthesis of claim 1 is characterized in that it may further comprise the steps:
(1) adopting the Biodegradable high-molecular polymer is raw material, is processed into monofilament, and monofilament is woven into braided support;
(2) in 0-300mg: the ratio of 1ml; With biodegradable medicine carrying substance dissolves in acetic acid or glycerol; Processing solution, is that sodium cholate and the disodium edetate of 0-10mol: 0-10mol is dispersed in the said biodegradable medicine carrying substance solution with mass ratio, through soaking or spray treatment; Place the braided support surface of above-mentioned steps (1) preparation, process the lithodialysis biliary tract prosthesis of biodegradable polymer braiding.
11., it is characterized in that in the described step (1), the diameter of monofilament is 0.1-2.0mm by the described method for preparing of claim 10.
12. by the described method for preparing of claim 10, it is characterized in that in the described step (1), the diameter of braided support is 6-10mm, length is 6-120mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100289046A CN102727943A (en) | 2011-11-14 | 2012-02-09 | Biodegradable polymer braided stone-dissolving bile duct stent and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110360149 | 2011-11-14 | ||
| CN201110360149.7 | 2011-11-14 | ||
| CN2012100289046A CN102727943A (en) | 2011-11-14 | 2012-02-09 | Biodegradable polymer braided stone-dissolving bile duct stent and preparation method thereof |
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| CN102727943A true CN102727943A (en) | 2012-10-17 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106581752A (en) * | 2017-01-23 | 2017-04-26 | 苏州大学 | Degradable medicine slow release function composite enteric stent and making method thereof |
| CN109172071A (en) * | 2018-07-10 | 2019-01-11 | 东南大学 | A kind of full overlay film degradable biliary tract rack and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106581752A (en) * | 2017-01-23 | 2017-04-26 | 苏州大学 | Degradable medicine slow release function composite enteric stent and making method thereof |
| CN109172071A (en) * | 2018-07-10 | 2019-01-11 | 东南大学 | A kind of full overlay film degradable biliary tract rack and preparation method thereof |
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Application publication date: 20121017 |